MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH RT THERAPIST 4.3.1; ACCELERATOR, LINEAR, MEDICAL

Device Problem Failure to Sense (1559)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens became aware of the reported issue on october 11, 2016 and the investigation is on-going.A supplemental report will be submitted upon completion.This information was requested and will be submitted with the supplement report when received.

Event Description

Siemens was notified on october 11, 2016 by the customer that they see a new function in rt therapist 4.3.1 that they did not see on rt therapist 4.2.It is reported that the issue of the "initial setup" appears only on patients that have been treated on an elekta machine and then gets transferred to rt therapist (artiste).With this occurrence, the system does not recognize the block tray and the patient could be accidently treated with an incorrect block inserted.However, there is no report of injury or mistreatment to a patient.This reported issue occurred in (b)(6).

• Brand Name: RT THERAPIST 4.3.1
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; medical solutions; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE; medical solutions; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; ms: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 6091648
• MDR Text Key: 59975841
• Report Number: 2240869-2016-57412
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K142434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Date Manufacturer Received: 10/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1